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Early cardiac damage detection with CMR in women with breast cancer

Early cardiac damage detection with CMR in women with breast cancer - Early cardiac damage detection with CMR in women with breast cancer

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48400
Enrollment
55
Registered
2019-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiac damage related to chemotherapy Chemotherapy induced cardiomyopathy

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Women diagnosed with primary breast cancer receiving (neo-) adjuvant chemotherapy Increased cardiotoxicity risk (intermediate, high, very high risk) Age * 18 years

Exclusion criteria

Exclusion criteria: Cancer recurrence Cancer metastasis History of myocardial infarction or heart failure

Design outcomes

Primary

MeasureTime frame
A relative reduction in GLS from baseline to 2 weeks (+/- 1 week) after chemotherapy discontinuation.—

Secondary

MeasureTime frame
Changes in circulating cardiac biomarkers (hs-Troponin T and NT-proBNP) compared with baseline, measured every 3 weeks before and after each chemotherapy cycle. The endpoint is a clinically significant increase in each biomarker above the normal value ranges between time points. Quality of Life (PROMs) will be evaluated after 1 and 3 years.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)